Recall Communications-third party disclosure (including Agency Guidance recommendations)

FDA Recall Regulations

OMB: 0910-0249

IC ID: 215023

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Recall Communications-third party disclosure (including Agency Guidance recommendations) ORA
 
No Modified
 
Voluntary
 
21 CFR 7.49

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

2,309 200
   
Private Sector Businesses or other for-profits
 
   95 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 2,558,372 0 0 1,321,717 0 1,236,655
Annual IC Time Burden (Hours) 127,919 0 0 66,086 0 61,833
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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